Elizabeth Anderson, Daniel Shaw Elected to FDLI's Board of Directors

Minnie Baylor-Henry, Geoffrey Levitt Become Chair, Vice Chair of Board; Patricia Shrader Named Treasurer

WASHINGTON, Jan. 10, 2011 /PRNewswire-USNewswire/ -- Elizabeth H. Anderson, Executive Vice President, Legal and General Counsel, at the Personal Care Products Council and Daniel F. Shaw, Vice President and Deputy General Counsel at H.J. Heinz Company, have been elected to the Food and Drug Law Institute's Board of Directors.

In addition, at the most recent Board meeting, Minnie V. Baylor-Henry, Worldwide Vice President for Regulatory Affairs at Johnson & Johnson Medical Devices & Diagnostics, became chair of the Board of Directors. Baylor-Henry succeeded Frederick H. Degnan, a Partner at King & Spalding's Washington, D.C. office, who remains on the Board as immediate past chair. Geoffrey M. Levitt, Senior Vice President and Associate General Counsel, Regulatory and Policy at Pfizer, Inc., succeeds Baylor-Henry as vice chair.  Patricia Shrader, Senior Vice President, Corporate Regulatory and External Affairs for BD, became Treasurer at the same meeting.

FDLI, founded in 1949, is a non-profit organization that provides a marketplace for discussing food and drug law issues through conferences, publications and member interaction. FDLI's scope includes food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices and tobacco.

Elizabeth H. (Betsy) Anderson is Executive Vice President-Legal and General Counsel for the Personal Care Products Council (PCPC). She is responsible for handling legal and regulatory issues facing the industry. Ms. Anderson also serves as PCPC's staff liaison to the Legal Executive Committee, the group responsible for guiding PCPC policy in the legal and regulatory areas. Before joining PCPC, Anderson was responsible for the legal and regulatory affairs of Beiersdorf, Inc., a manufacturer of over-the-counter (OTC) drugs, medical devices and cosmetics in Norwalk, Connecticut. Anderson graduated with honors from Bowdoin College and received her law degree from Boston College Law School. Fluent in German, she spent two years at the Institute of European Studies in Vienna, Austria. Her FDLI service, in addition to serving on the Food and Drug Law Journal Editorial Advisory Board from 2003-2006, includes attending numerous meetings and contributing the following chapters: "FDA Regulation of Personal Care Products,"  Nanotechnology & FDA-Regulated Products: The Essential Guide (2009) and "The Cosmetic Regulatory Process," A Practical Guide to Food and Drug Law and Regulation, Third Edition (2008).

Daniel F. Shaw is Vice President and Deputy General Counsel of H. J. Heinz Company. He is responsible for its North American legal affairs. In addition to food law, he is involved with a variety of other legal work, including mergers and acquisitions, general commercial and regulatory work. He began his career with the U.S. Department of Justice and subsequently moved to a Washington, DC law firm with a food, drug and legislative practice. His participation with FDLI includes being a member of the Foods and Dietary Supplements committee from 2004-2011, the Food and Drug Law Journal Editorial Advisory Board from 2002-2006, the Membership committee from 2004-2007, and serving frequently as a conference speaker.  Shaw graduated from Williams College and received his law degree from the Dickinson School of Law.

Minnie V. Baylor-Henry is the Worldwide Vice-President for Regulatory Affairs, Johnson & Johnson (J&J) Medical Devices & Diagnostics. In this role, she is responsible for coordinating the regulatory strategy for the device sector at J&J, as well as chairing the Regulatory Council for Devices. Prior to returning to J&J, she was a national director in the government, regulatory & risk practice at Deloitte & Touche, with a practice focus on regulatory life sciences, including medical devices, pharmaceuticals and consumer products.  Prior to joining Deloitte & Touche, Baylor-Henry worked in several roles at J&J in the Pharmaceutical and Consumer Sectors. She began her J&J career at J&J Pharmaceutical Research & Development as a Senior Director for Regulatory Affairs. She was promoted to Vice President, U.S. Medical & Regulatory Affairs for McNeil Pediatrics, where she had responsibility for many medical, as well as regulatory, functions. Within the Consumer sector, Baylor-Henry was the global Vice President for OTC Regulatory Affairs for McNeil Consumer Healthcare. Before joining J&J, she worked for FDA from 1991-1999. During her career at FDA, she had many roles, most notably, FDA's National Health Fraud Coordinator and the director of the Division of Drug Marketing, Advertising, and Communications (DDMAC) from 1995-1999. She received her Pharmacy degree from Howard University's College of Pharmacy and her law degree from Catholic University's Columbus School of Law.

Geoffrey M. Levitt is Senior Vice President and Associate General Counsel, Regulatory & Policy, Pfizer, Inc. Previously, he served as associate general counsel and chief regulatory counsel at Wyeth where he was responsible for a wide range of legal/regulatory issues related to Board of Health regulation and compliance worldwide. Prior to joining Wyeth, Levitt was a partner and co-chair of the food and drug law group at Venable, Baetjer, Howard & Civiletti in Washington, DC. He has published and lectured extensively on food and drug law, and is a past member of the editorial board of the Food and Drug Law Journal and a current member of the editorial board of the FDA Advertising and Promotion Manual.  Levitt is a recipient of the Food and Drug Law Institute's 2009 Distinguished Service and Leadership Award. His most recent publications include the book Competitive Challenges in the Drug Approval Process: Generics, Hybrids and Follow-on Biologics (2005) and the chapter "The Drugs/Biologics Approval Process" in A Practical Guide to Food and Drug Law and Regulation (Food and Drug Law Institute, 3d ed. 2008). Mr. Levitt received his BA from Columbia University and his law degree from Harvard Law School.

Frederick H. Degnan is a Partner in King & Spalding's Washington, DC office and is part of the firm's FDA & Life Sciences Practice Group. He specializes in food and drug law and handles a wide array of food safety, labeling, and biotechnology issues. His prior eleven-plus year legal career in the Food and Drug Administration's (FDA's) Office of Chief Counsel (where he served as associate chief counsel for foods, associate chief counsel for veterinary medicine and associate chief counsel for enforcement) included extensive experience with food and drug issues, including food safety, nutrition and health, infant formula, labeling, good manufacturing practice, new drugs, new animal drugs, and the use of risk assessment in the regulation of the safety of food ingredients. He also had substantial FDA litigation and enforcement experience in federal courts. From 1988 to 2010, Degnan taught food and drug law at the Catholic University of America's Columbus School of Law where he served as a "Distinguished Lecturer." He has published and lectured extensively on FDA-related issues and is the author of the book, FDA's Creative Application of the Law: Not Merely a Collection of Words (2nd Edition), a consideration of FDA's implementation of its statutory authority to adapt to the practical demands of modern regulation. In 2002, he received the FDLI Distinguished Leadership Award for his contributions to the food and drug community. Degnan received his undergraduate degree, cum laude, from the College of the Holy Cross, Worcester, Massachusetts and his law degree from the Georgetown University Law Center.

Patricia B. Shrader is Senior Vice President, Corporate Regulatory and External Affairs for BD, a medical technology company. In this position, she is responsible for all regulatory activities within BD worldwide, as well as serving as the primary interface with agencies and trade associates. She also has responsibility for Government Relations/Public Policy, Communications/Public Relations and Social Investing. Previously, Shrader was Counsel with the law firm of Hogan & Hartson, where her practice focused primarily on medical devices, with an emphasis on product submissions and GMP issues. Prior to joining Hogan & Hartson, she was the Director of Quality Assurance and Regulatory Affairs at Whittaker Bioproducts, Inc. Shrader is a frequent speaker at various professional meetings and is active in FDLI, AdvaMed, and RAPS. She has also contributed numerous articles to MDM Magazine and IVD Technology. Shrader received her law degree from the Georgetown University Law Center.

For a complete list of FDLI's Board of Directors, visit www.fdli.org.

SOURCE Food and Drug Law Institute